Pradaxa is the first of the new generation anticoagulant drugs introduced in 2010.

However, reports of serious and even life-threatening side effects have prompted the Food and Drug Administration (FDA) to evaluate potential dangers associated with this drug.

One of the most concerning Pradaxa side effects is cerebral hemorrhaging, which can quickly cause permanent damage to brain tissue and even death, if not treated promptly.

What is a Pradaxa Cerebral Hemorrhage?

A cerebral hemorrhage occurs when an artery in the brain bursts and causes bleeding in the brain. The pressure from the localized bleeding can kill brain cells and lead to death in some cases.

Symptoms of Pradaxa bleeding and cerebral hemorrhage include:

• Sudden headache
• Chest pain and pressure
• Changes in vision
• Tingling or numbness
• Difficulty speaking or swallowing
• Loss of coordination and balance
• Nausea or vomiting
• Loss of consciousness

Pradaxa Bleeding Complications

Pradaxa is a direct thrombin inhibitor used to reduce the risk of stroke and embolism in patients with non-valvular atrial fibrillation. It was approved by the U.S. Food and Drug Administration (FDA) in 2010 and was the first anti-coagulant to be introduced in the United States in more than 50 years.

Anticoagulants always carry a bleeding risk, but the alternative to Pradaxa, Warfarin (Coumadin), offers an antidote to reverse bleeding if it occurs.  The Institute for Safe Medicine Practices released a report in January 2012, citing 505 cases of Pradaxa bleeding. The alternative anticoagulant, Warfarin, only had 176 reports.

The Journal of Neurosurgery has also reported that doctors should be alerted to the potential for brain hemorrhage in patients taking the generic form of Pradaxa.

Soon after FDA approval, reports began to show that Pradaxa could cause serious and potentially irreversible internal bleeding. Within the first six months after the drug’s release, the FDA received more than 500 reports of internal bleeding and deaths from conditions like brain hemorrhages.

While the FDA approved a Pradaxa antidote in December 2015, this bleeding reversal agent came too late for many patients who suffered serious and sometimes fatal bleeding events.

With the lack of a Pradaxa antidote for more than five years, this meant that if a brain hemorrhage occurred, doctors had few options in effectively treating the bleeding.

Pradaxa Bleeding Lawsuits

Pradaxa lawsuits have been consolidated into federal multidistrict litigation, In re: Pradaxa Product Liability Litigation, MDL No. 2385, U.S. District Court for the Southern District of Illinois, pending before Judge David R. Herndon.

These Pradaxa lawsuits are being filed by people who suffered serious, life-threatening internal bleeding while using this anticoagulant and claim that the drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals, failed to adequately warn patients about Pradaxa side effects such as:

• Cerebral hemorrhage – Pradaxa bleeding in the brain
• Gastrointestinal (stomach) bleeding
• Severe Pradaxa internal bleeding following a minor trauma, such as a fall
• Death from serious Pradaxa internal bleeding

You may be eligible to file your own Pradaxa bleeding lawsuit if you or someone you care about suffered a serious episode of internal bleeding or cerebral hemorrhaging.